Status:

COMPLETED

Evaluation the Safety and Tolerance of GP681 Tablets in Healthy Subjects

Lead Sponsor:

Jiangxi Qingfeng Pharmaceutical Co. Ltd.

Conditions:

Influenza

Eligibility:

All Genders

18-45 years

Phase:

PHASE1

Brief Summary

Influenza (influenza for short) is an acute respiratory infectious disease caused by influenza virus. The symptoms of the disease range from mild, moderate to severe, and severe cases require hospital...

Detailed Description

The GP681 in this test is a prodrug of a polymerase acidic protein (PA, Polymerase Acidic protein) inhibitor. Its metabolite GP1707D07 can selectively inhibit the cap-dependent endonuclease of influen...

Eligibility Criteria

Inclusion

  • \- 18-45 years old, male or female (the food impact test is limited to males); male ≥50 kg, female ≥45kg,BMI19-26; Fully understand the purpose and requirements of this trial, voluntarily participate in the clinical trial and sign a written informed consent form, and be able to complete the entire trial process according to the trial requirements.

Exclusion

  • \- history of allergies, allergic diseases or allergies to drugs in research; medical history of the central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, blood system, metabolic disorders, etc. or other diseases that are not suitable for participating in clinical trials (such as mental illness history, etc.); donated blood or blood loss ≥ 400 mL within 3 months before enrollment;

Key Trial Info

Start Date :

August 27 2020

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 15 2020

Estimated Enrollment :

56 Patients enrolled

Trial Details

Trial ID

NCT04729764

Start Date

August 27 2020

End Date

December 15 2020

Last Update

January 28 2021

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Shanghai Xuhui Central Hospital

Shanghai, Shanghai Municipality, China, 200031